Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, children, infants, pimecrolimus
Brief summary
The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).
Interventions
DRUGPimecrolimus
Pimecrolimus cream 1 %
TCS
Sponsors
MEDA Pharma GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
* Aged 3 to \< 12 months * Diagnosis of AD fulfilling the diagnostic criteria of Seymour * AD affecting at least 5% total body surface area * Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline * Informed consent
Exclusion criteria
* Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks * Topical tacrolimus or pimecrolimus within 2 weeks * Topical therapy (e.g., tar, topical corticosteroids) within 3 days * Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease * Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD * Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile * Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids * Clinical conditions other than AD that according to investigator can interfere with the evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessed by Adverse Events | throughout the 5-year study | crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period |
| Growth Velocity (Height) | throughout the 5-year study | — |
| Growth Velocity (Weight) | throughout the 5-year study | — |
| Potential Effect on the Developing Immune System | throughout the 5-year study | number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | throughout the 5-year study | IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI\<0 is set to 0, upper CI\>100 is set to 100. Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success. |
| Vital Signs and Physical Examinations: Pulse | throughout the 5-year study | Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start. |
| Body Surface Area Involved With Atopic Dermatitis | throughout the 5-year study | TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100. |
| Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | throughout the 5-year study | PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US. For the purposes of data presentation, a Not True response was coded a value of zero and a True a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing. |
| Vital Signs and Physical Examinations: Blood Pressure (BP) | throughout the 5-year study | Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start. |
Countries
Germany, United States
Participant flow
Recruitment details
First patient was enrolled into the study on 05 Apr 2004, last patient completed on 04 Oct 2010.
Participants by arm
| Arm | Count |
|---|---|
| Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver | 1,205 |
| Topical Corticosteroids Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently. | 1,213 |
| Total | 2,418 |
Baseline characteristics
| Characteristic | Pimecrolimus | Topical Corticosteroids | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1205 Participants | 1213 Participants | 2418 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.1 months STANDARD_DEVIATION 2.71 | 7.1 months STANDARD_DEVIATION 2.66 | 7.1 months STANDARD_DEVIATION 2.69 |
| Region of Enrollment Argentina | 40 participants | 40 participants | 80 participants |
| Region of Enrollment Belgium | 20 participants | 16 participants | 36 participants |
| Region of Enrollment Canada | 52 participants | 64 participants | 116 participants |
| Region of Enrollment Chile | 25 participants | 22 participants | 47 participants |
| Region of Enrollment China | 60 participants | 59 participants | 119 participants |
| Region of Enrollment Colombia | 48 participants | 52 participants | 100 participants |
| Region of Enrollment Czech Republic | 26 participants | 23 participants | 49 participants |
| Region of Enrollment Ecuador | 15 participants | 13 participants | 28 participants |
| Region of Enrollment Germany | 130 participants | 131 participants | 261 participants |
| Region of Enrollment Greece | 19 participants | 16 participants | 35 participants |
| Region of Enrollment Guatemala | 53 participants | 56 participants | 109 participants |
| Region of Enrollment Hong Kong | 5 participants | 4 participants | 9 participants |
| Region of Enrollment Hungary | 39 participants | 40 participants | 79 participants |
| Region of Enrollment Iceland | 97 participants | 98 participants | 195 participants |
| Region of Enrollment Netherlands | 51 participants | 55 participants | 106 participants |
| Region of Enrollment Peru | 55 participants | 51 participants | 106 participants |
| Region of Enrollment Poland | 37 participants | 36 participants | 73 participants |
| Region of Enrollment Portugal | 5 participants | 5 participants | 10 participants |
| Region of Enrollment Russian Federation | 54 participants | 53 participants | 107 participants |
| Region of Enrollment Singapore | 12 participants | 13 participants | 25 participants |
| Region of Enrollment South Africa | 49 participants | 55 participants | 104 participants |
| Region of Enrollment Spain | 51 participants | 48 participants | 99 participants |
| Region of Enrollment Sweden | 29 participants | 29 participants | 58 participants |
| Region of Enrollment Taiwan | 30 participants | 30 participants | 60 participants |
| Region of Enrollment Turkey | 26 participants | 28 participants | 54 participants |
| Region of Enrollment United Kingdom | 32 participants | 27 participants | 59 participants |
| Region of Enrollment United States | 106 participants | 110 participants | 216 participants |
| Region of Enrollment Venezuela | 39 participants | 39 participants | 78 participants |
| Sex: Female, Male Female | 461 Participants | 471 Participants | 932 Participants |
| Sex: Female, Male Male | 744 Participants | 742 Participants | 1486 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1,162 / 1,205 | 1,160 / 1,213 |
| serious Total, serious adverse events | 247 / 1,205 | 210 / 1,213 |
Outcome results
Primary
Growth Velocity (Height)
Time frame: throughout the 5-year study
Population: Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pimecrolimus | Growth Velocity (Height) | Week 156 (n=871, n=919) | 100.5 cm | Standard Deviation 4.7 |
| Pimecrolimus | Growth Velocity (Height) | Week 26 (n=1092, n=1114) | 77.0 cm | Standard Deviation 4.37 |
| Pimecrolimus | Growth Velocity (Height) | Baseline (n=1204, n=1208) | 68.8 cm | Standard Deviation 5.26 |
| Pimecrolimus | Growth Velocity (Height) | Week 52 (n=999, n=1052) | 83.1 cm | Standard Deviation 4.23 |
| Pimecrolimus | Growth Velocity (Height) | Week 208 (n=843, n=869) | 107.7 cm | Standard Deviation 5.46 |
| Pimecrolimus | Growth Velocity (Height) | Week 104 (n=924, n=975) | 93.0 cm | Standard Deviation 4.31 |
| Pimecrolimus | Growth Velocity (Height) | Week 260 (n=833, n=871) | 114.4 cm | Standard Deviation 5.26 |
| Pimecrolimus | Growth Velocity (Height) | Week 6 (n=1144, n=1141) | 71.3 cm | Standard Deviation 4.82 |
| Topical Corticosteroids | Growth Velocity (Height) | Week 260 (n=833, n=871) | 114.5 cm | Standard Deviation 5.9 |
| Topical Corticosteroids | Growth Velocity (Height) | Week 156 (n=871, n=919) | 100.6 cm | Standard Deviation 4.72 |
| Topical Corticosteroids | Growth Velocity (Height) | Week 208 (n=843, n=869) | 107.8 cm | Standard Deviation 5.25 |
| Topical Corticosteroids | Growth Velocity (Height) | Baseline (n=1204, n=1208) | 68.8 cm | Standard Deviation 5.14 |
| Topical Corticosteroids | Growth Velocity (Height) | Week 6 (n=1144, n=1141) | 71.3 cm | Standard Deviation 4.76 |
| Topical Corticosteroids | Growth Velocity (Height) | Week 26 (n=1092, n=1114) | 76.9 cm | Standard Deviation 4.46 |
| Topical Corticosteroids | Growth Velocity (Height) | Week 52 (n=999, n=1052) | 83.1 cm | Standard Deviation 4.3 |
| Topical Corticosteroids | Growth Velocity (Height) | Week 104 (n=924, n=975) | 92.9 cm | Standard Deviation 4.3 |
Primary
Growth Velocity (Weight)
Time frame: throughout the 5-year study
Population: Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pimecrolimus | Growth Velocity (Weight) | Week 52 (n=1003, n=1054) | 11.6 kg | Standard Deviation 1.52 |
| Pimecrolimus | Growth Velocity (Weight) | Week 6 (n=1144, n=1144) | 8.8 kg | Standard Deviation 1.45 |
| Pimecrolimus | Growth Velocity (Weight) | Week 104 (n=928, n=978) | 14.1 kg | Standard Deviation 1.9 |
| Pimecrolimus | Growth Velocity (Weight) | Baseline (n=1203, n=1213) | 8.2 kg | Standard Deviation 1.51 |
| Pimecrolimus | Growth Velocity (Weight) | Week 208 (n=843, n=870) | 18.6 kg | Standard Deviation 2.8 |
| Pimecrolimus | Growth Velocity (Weight) | Week 26 (n=1093, n=1114) | 10.2 kg | Standard Deviation 1.43 |
| Pimecrolimus | Growth Velocity (Weight) | Week 260 (n=833, n=871) | 21.1 kg | Standard Deviation 3.51 |
| Pimecrolimus | Growth Velocity (Weight) | Week 156 (n=873, n=924) | 16.3 kg | Standard Deviation 2.32 |
| Topical Corticosteroids | Growth Velocity (Weight) | Week 260 (n=833, n=871) | 21.4 kg | Standard Deviation 3.7 |
| Topical Corticosteroids | Growth Velocity (Weight) | Baseline (n=1203, n=1213) | 8.2 kg | Standard Deviation 1.51 |
| Topical Corticosteroids | Growth Velocity (Weight) | Week 6 (n=1144, n=1144) | 8.7 kg | Standard Deviation 1.41 |
| Topical Corticosteroids | Growth Velocity (Weight) | Week 26 (n=1093, n=1114) | 10.1 kg | Standard Deviation 1.39 |
| Topical Corticosteroids | Growth Velocity (Weight) | Week 52 (n=1003, n=1054) | 11.6 kg | Standard Deviation 1.54 |
| Topical Corticosteroids | Growth Velocity (Weight) | Week 156 (n=873, n=924) | 16.3 kg | Standard Deviation 2.29 |
| Topical Corticosteroids | Growth Velocity (Weight) | Week 208 (n=843, n=870) | 18.7 kg | Standard Deviation 2.88 |
| Topical Corticosteroids | Growth Velocity (Weight) | Week 104 (n=928, n=978) | 14.1 kg | Standard Deviation 1.83 |
Primary
Potential Effect on the Developing Immune System
number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.
Time frame: throughout the 5-year study
Population: Immune system function data analyses were performed on the immunology set (774 patients). Varicella titers were assessed for USA patients only (n= 104, n=108).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pimecrolimus | Potential Effect on the Developing Immune System | Measles Baseline | 11.4 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Tetanus week 156 | 93.5 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Measles week 26 | 37.4 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Hepatitis B week 26 | 60.7 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Measles week 52 | 86.3 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Tetanus week 26 | 89.5 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Measles week 104 | 97.3 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Hepatitis B week 52 | 59.0 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Measles week 156 | 98.5 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Tetanus week 208 | 89.0 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Measles week 208 | 97.8 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Hepatitis B week 104 | 51.5 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Measles week 260 | 98.9 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Tetanus week 104 | 91.9 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Varicella Baseline | 32.1 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Hepatitis B week 156 | 48.5 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Varicella week 26 | 46.5 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Tetanus week 260 | 91.1 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Varicella week 52 | 72.2 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Hepatitis B week 208 | 39.7 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Varicella week 104 | 78.4 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Tetanus week 52 | 91.9 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Varicella week 156 | 68.4 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Hepatitis B week 260 | 34.6 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Varicella week 208 | 86.1 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Hepatitis B Baseline | 57.5 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Varicella week 260 | 87.1 % of patients with positive ab titer |
| Pimecrolimus | Potential Effect on the Developing Immune System | Tetanus Baseline | 81.8 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Varicella week 260 | 84.1 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Tetanus Baseline | 85.2 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Tetanus week 26 | 90.4 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Tetanus week 52 | 94.0 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Tetanus week 104 | 94.7 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Tetanus week 156 | 92.5 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Tetanus week 208 | 89.5 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Tetanus week 260 | 88.9 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Hepatitis B Baseline | 53.6 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Hepatitis B week 26 | 58.6 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Hepatitis B week 52 | 58.5 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Hepatitis B week 104 | 51.3 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Hepatitis B week 156 | 45.0 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Hepatitis B week 208 | 38.5 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Hepatitis B week 260 | 38.2 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Measles Baseline | 14.4 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Measles week 26 | 31.6 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Measles week 52 | 86.1 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Measles week 104 | 97.4 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Measles week 156 | 97.0 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Measles week 208 | 95.6 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Measles week 260 | 96.3 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Varicella Baseline | 17.8 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Varicella week 26 | 45.2 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Varicella week 52 | 74.2 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Varicella week 104 | 88.7 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Varicella week 156 | 81.8 % of patients with positive ab titer |
| Topical Corticosteroids | Potential Effect on the Developing Immune System | Varicella week 208 | 89.4 % of patients with positive ab titer |
Primary
Safety Assessed by Adverse Events
crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period
Time frame: throughout the 5-year study
Population: complete safety/ITT population of experimental and control
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pimecrolimus | Safety Assessed by Adverse Events | Influenza | 6.9 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Dermatitis diaper | 12.5 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Influenza like illness | 16.7 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Allergy to arthropod bite | 5.9 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Laryngitis | 5.4 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Diarrhoea | 31.9 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Lower respiratory tract infection | 3.7 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Bronchospasm | 5.2 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Molluscum contagiosum | 9.0 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Eczema infected | 7.4 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Nasopharyngitis | 59.0 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Asthma | 15.1 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Otitis media | 34.7 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Eye infection | 0.3 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Otitis media acute | 12.4 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Conjunctivitis | 16.5 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Pharyngitis | 17.8 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Food allergy | 7.4 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Pneumonia | 11.0 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Rhinitis | 13.9 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Acute tonsillitis | 8.6 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Rhinitis allergic | 13.2 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Gastroenteritis | 28.2 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Rhinorrhoea | 6.8 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Conjunctivitis allergic | 5.0 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Sinusitis | 7.6 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Gastroenteritis viral | 6.1 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Teething | 14.9 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Bronchiolitis | 5.4 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Tonsillitis | 16.9 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Heat rash | 5.5 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Upper respiratory tract infection | 32.0 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Constipation | 6.9 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Urinary tract infection | 4.3 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Hypersensitivity | 2.0 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Urticaria | 9.5 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Arthropod bite | 7.1 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Varicella | 25.4 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Immunisation reaction | 6.5 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Viral rash | 3.0 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Cough | 29.9 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Viral upper respiratory tract infection | 10.5 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Impetigo | 11.9 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Vomiting | 22.5 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Bronchitis | 36.3 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Wheezing | 5.6 percentage of participants |
| Pimecrolimus | Safety Assessed by Adverse Events | Pyrexia | 48.9 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Wheezing | 5.3 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Pyrexia | 49.9 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Pneumonia | 10.8 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Acute tonsillitis | 7.8 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Allergy to arthropod bite | 4.9 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Arthropod bite | 8.8 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Asthma | 14.6 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Bronchiolitis | 5.7 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Bronchitis | 33.8 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Bronchospasm | 6.7 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Conjunctivitis | 16.2 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Conjunctivitis allergic | 6.3 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Constipation | 6.7 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Cough | 30.4 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Dermatitis diaper | 11.3 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Diarrhoea | 31.4 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Eczema infected | 4.5 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Eye infection | 0.3 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Food allergy | 6.0 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Gastroenteritis | 27.1 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Gastroenteritis viral | 5.2 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Heat rash | 4.8 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Hypersensitivity | 1.9 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Immunisation reaction | 5.5 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Impetigo | 10.4 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Influenza | 5.7 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Influenza like illness | 16.6 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Laryngitis | 4.9 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Lower respiratory tract infection | 4.5 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Molluscum contagiosum | 8.2 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Nasopharyngitis | 58.9 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Otitis media | 31.7 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Otitis media acute | 11.6 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Pharyngitis | 19.0 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Rhinitis | 13.4 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Rhinitis allergic | 12.7 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Rhinorrhoea | 6.8 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Sinusitis | 8.1 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Teething | 14.9 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Tonsillitis | 16.5 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Upper respiratory tract infection | 31.2 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Urinary tract infection | 5.2 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Urticaria | 10.6 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Varicella | 23.4 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Viral rash | 4.1 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Viral upper respiratory tract infection | 10.4 percentage of participants |
| Topical Corticosteroids | Safety Assessed by Adverse Events | Vomiting | 21.3 percentage of participants |
Secondary
Body Surface Area Involved With Atopic Dermatitis
TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.
Time frame: throughout the 5-year study
Population: Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pimecrolimus | Body Surface Area Involved With Atopic Dermatitis | Baseline (n=1205, n=1213) | 21.1 percentage of TBSA affected | Standard Deviation 16.5 |
| Pimecrolimus | Body Surface Area Involved With Atopic Dermatitis | Week 104 (n=922, n=975) | 2.4 percentage of TBSA affected | Standard Deviation 6.53 |
| Pimecrolimus | Body Surface Area Involved With Atopic Dermatitis | Week 26 (n=1091, n=1113) | 4.3 percentage of TBSA affected | Standard Deviation 8.3 |
| Pimecrolimus | Body Surface Area Involved With Atopic Dermatitis | Week 156 (n=871, n=918) | 2.0 percentage of TBSA affected | Standard Deviation 5.46 |
| Pimecrolimus | Body Surface Area Involved With Atopic Dermatitis | Week 6 (n=1142, n=1138) | 5.5 percentage of TBSA affected | Standard Deviation 8.72 |
| Pimecrolimus | Body Surface Area Involved With Atopic Dermatitis | Week 208 (n=843, n=868) | 1.5 percentage of TBSA affected | Standard Deviation 5.16 |
| Pimecrolimus | Body Surface Area Involved With Atopic Dermatitis | Week 52 (n=997, n=1048) | 3.5 percentage of TBSA affected | Standard Deviation 7.69 |
| Pimecrolimus | Body Surface Area Involved With Atopic Dermatitis | Week 260 (n=833, n=870) | 1.1 percentage of TBSA affected | Standard Deviation 3.31 |
| Topical Corticosteroids | Body Surface Area Involved With Atopic Dermatitis | Week 260 (n=833, n=870) | 0.9 percentage of TBSA affected | Standard Deviation 3.69 |
| Topical Corticosteroids | Body Surface Area Involved With Atopic Dermatitis | Baseline (n=1205, n=1213) | 21.3 percentage of TBSA affected | Standard Deviation 17.19 |
| Topical Corticosteroids | Body Surface Area Involved With Atopic Dermatitis | Week 6 (n=1142, n=1138) | 6.0 percentage of TBSA affected | Standard Deviation 9.1 |
| Topical Corticosteroids | Body Surface Area Involved With Atopic Dermatitis | Week 26 (n=1091, n=1113) | 3.7 percentage of TBSA affected | Standard Deviation 8.5 |
| Topical Corticosteroids | Body Surface Area Involved With Atopic Dermatitis | Week 52 (n=997, n=1048) | 2.7 percentage of TBSA affected | Standard Deviation 6.27 |
| Topical Corticosteroids | Body Surface Area Involved With Atopic Dermatitis | Week 104 (n=922, n=975) | 1.8 percentage of TBSA affected | Standard Deviation 5.17 |
| Topical Corticosteroids | Body Surface Area Involved With Atopic Dermatitis | Week 156 (n=871, n=918) | 1.4 percentage of TBSA affected | Standard Deviation 4.65 |
| Topical Corticosteroids | Body Surface Area Involved With Atopic Dermatitis | Week 208 (n=843, n=868) | 1.2 percentage of TBSA affected | Standard Deviation 4.33 |
Secondary
Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate
IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI\<0 is set to 0, upper CI\>100 is set to 100. Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success.
Time frame: throughout the 5-year study
Population: Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 52 | 73.9 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 260 | 88.7 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 6 | 68.9 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 26 | 79.5 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 104 | 79.9 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 52 | 85.6 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 26 | 66.4 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 104 | 92.1 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 156 | 94.2 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 156 | 81.9 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 208 | 96.0 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 6 | 61.4 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 260 | 96.6 percentage of participants |
| Pimecrolimus | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 208 | 86.2 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 260 | 97.2 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 260 | 92.3 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 6 | 71.0 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 104 | 94.1 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 6 | 59.6 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 26 | 74.5 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 104 | 83.4 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 156 | 86.1 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 208 | 88.1 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 26 | 83.8 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 52 | 88.5 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 156 | 94.3 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Facial IGA Week 208 | 96.2 percentage of participants |
| Topical Corticosteroids | Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate | Overall IGA Week 52 | 79.6 percentage of participants |
Secondary
Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US. For the purposes of data presentation, a Not True response was coded a value of zero and a True a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing.
Time frame: throughout the 5-year study
Population: Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication. Patients who do not have baseline value are excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pimecrolimus | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 104 (n=302, n=296) | 3.7 units on a scale | Standard Deviation 4.69 |
| Pimecrolimus | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 26 (n=368, n=363) | 4.8 units on a scale | Standard Deviation 4.73 |
| Pimecrolimus | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 156 (n=269, n=266) | 3.2 units on a scale | Standard Deviation 4.67 |
| Pimecrolimus | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Baseline (n=406, n=405) | 8.1 units on a scale | Standard Deviation 5.04 |
| Pimecrolimus | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 208 (n=254, n=256) | 2.7 units on a scale | Standard Deviation 3.93 |
| Pimecrolimus | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 52 (n=327, n=334) | 4.2 units on a scale | Standard Deviation 4.45 |
| Pimecrolimus | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 260 (n=249, 249) | 2.1 units on a scale | Standard Deviation 3.22 |
| Pimecrolimus | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 6 (n=378, n=360) | 5.8 units on a scale | Standard Deviation 4.76 |
| Topical Corticosteroids | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 260 (n=249, 249) | 2.3 units on a scale | Standard Deviation 3.8 |
| Topical Corticosteroids | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Baseline (n=406, n=405) | 8.4 units on a scale | Standard Deviation 5.25 |
| Topical Corticosteroids | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 26 (n=368, n=363) | 5.0 units on a scale | Standard Deviation 4.85 |
| Topical Corticosteroids | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 52 (n=327, n=334) | 4.4 units on a scale | Standard Deviation 4.94 |
| Topical Corticosteroids | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 104 (n=302, n=296) | 3.9 units on a scale | Standard Deviation 5.14 |
| Topical Corticosteroids | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 156 (n=269, n=266) | 3.4 units on a scale | Standard Deviation 5.02 |
| Topical Corticosteroids | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 208 (n=254, n=256) | 3.0 units on a scale | Standard Deviation 4.88 |
| Topical Corticosteroids | Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) | Week 6 (n=378, n=360) | 6.0 units on a scale | Standard Deviation 5.09 |
Secondary
Vital Signs and Physical Examinations: Blood Pressure (BP)
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Time frame: throughout the 5-year study
Population: Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP - Baseline | 94.3 mmHg | Standard Deviation 12.4 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 6 | 96.1 mmHg | Standard Deviation 11.7 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 26 | 98.6 mmHg | Standard Deviation 11.46 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 52 | 99.0 mmHg | Standard Deviation 11.33 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 104 | 98.8 mmHg | Standard Deviation 10.01 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 156 | 99.0 mmHg | Standard Deviation 9.47 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 208 | 99.8 mmHg | Standard Deviation 10.1 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 260 | 100.0 mmHg | Standard Deviation 9.51 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Baseline | 59.2 mmHg | Standard Deviation 10.4 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 6 | 60.4 mmHg | Standard Deviation 9.47 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 26 | 61.7 mmHg | Standard Deviation 9.9 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 52 | 61.9 mmHg | Standard Deviation 9.12 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 104 | 61.8 mmHg | Standard Deviation 8.14 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 156 | 62.0 mmHg | Standard Deviation 8.11 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 208 | 62.4 mmHg | Standard Deviation 8.52 |
| Pimecrolimus | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 260 | 61.9 mmHg | Standard Deviation 7.24 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 260 | 62.2 mmHg | Standard Deviation 7.38 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP - Baseline | 94.7 mmHg | Standard Deviation 12.79 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Baseline | 59.1 mmHg | Standard Deviation 10.26 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 6 | 96.3 mmHg | Standard Deviation 11.33 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 104 | 61.7 mmHg | Standard Deviation 7.72 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 26 | 98.4 mmHg | Standard Deviation 11.49 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 6 | 61.0 mmHg | Standard Deviation 9.59 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 52 | 99.3 mmHg | Standard Deviation 11.02 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 208 | 61.8 mmHg | Standard Deviation 7.77 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 104 | 97.9 mmHg | Standard Deviation 9.85 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 26 | 61.6 mmHg | Standard Deviation 9.78 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 156 | 98.6 mmHg | Standard Deviation 9.75 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 156 | 62.0 mmHg | Standard Deviation 8.29 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 208 | 99.4 mmHg | Standard Deviation 9.74 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Diastolic BP - Week 52 | 61.9 mmHg | Standard Deviation 9.23 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Blood Pressure (BP) | Systolic BP- Week 260 | 100.1 mmHg | Standard Deviation 9.63 |
Secondary
Vital Signs and Physical Examinations: Pulse
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Time frame: throughout the 5-year study
Population: Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pimecrolimus | Vital Signs and Physical Examinations: Pulse | Baseline | 116.7 bpm | Standard Deviation 19.43 |
| Pimecrolimus | Vital Signs and Physical Examinations: Pulse | Week 6 | 114.2 bpm | Standard Deviation 18.19 |
| Pimecrolimus | Vital Signs and Physical Examinations: Pulse | Week 26 | 111.4 bpm | Standard Deviation 18.09 |
| Pimecrolimus | Vital Signs and Physical Examinations: Pulse | Week 52 | 107.7 bpm | Standard Deviation 18.63 |
| Pimecrolimus | Vital Signs and Physical Examinations: Pulse | Week 104 | 101.7 bpm | Standard Deviation 15.97 |
| Pimecrolimus | Vital Signs and Physical Examinations: Pulse | Week 156 | 97.4 bpm | Standard Deviation 13.45 |
| Pimecrolimus | Vital Signs and Physical Examinations: Pulse | Week 208 | 93.4 bpm | Standard Deviation 12.78 |
| Pimecrolimus | Vital Signs and Physical Examinations: Pulse | Week 260 | 90.2 bpm | Standard Deviation 12.82 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Pulse | Week 260 | 90.4 bpm | Standard Deviation 12.25 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Pulse | Baseline | 116.0 bpm | Standard Deviation 19.69 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Pulse | Week 104 | 101.8 bpm | Standard Deviation 15.91 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Pulse | Week 6 | 114.5 bpm | Standard Deviation 19.45 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Pulse | Week 208 | 93.4 bpm | Standard Deviation 12.56 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Pulse | Week 26 | 111.7 bpm | Standard Deviation 18.44 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Pulse | Week 156 | 97.0 bpm | Standard Deviation 13.72 |
| Topical Corticosteroids | Vital Signs and Physical Examinations: Pulse | Week 52 | 107.0 bpm | Standard Deviation 17.92 |